Certificate To Foreign Government FDA
Overview
Certificate to foreign government FDA is required by many medical device market regulators in Asia, the Middle East, and Latin America in order to legally sell your product in their territories. A CFG confirms that your device has been cleared or approved for sale in the US. You can present your CFG to regulators in these markets as part of your medical device registration process. For the registration process or for the approval process you need experience Medical device compliance and regulatory service provider who can work with you to solve the raised issue if any.
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Before certain medical devices can be lawfully exported from the United States, some countries require American companies to obtain a Certificate to foreign government FDA (CFG). The FDA recently issued a final guidance titled “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices,” which details how to seek review of the denial of a CFG request, as well as the reasons the FDA will deny such a request and how to rectify them.
Certificates to foreign government FDA are product specific and cost $175 for the original certificate. Each additional copy (official copies from the FDA are usually required) costs $15 per copy. Up to 50 pages (including the certificate, manufacturer page, and attachment pages) may be submitted for the same product. Each time an increment of 50 pages is exceeded, an additional fee of $175 will be charged.
If the original is three pages long and you request an original and ten copies (33 total pages), then your charge will be $175 for the original and $150 for the ten copies–a combined total of $325. However, original and 20 copies (63 pages) would exceed the 50-page limit, and you would be charged $175 for the first original and $225 for the first 15 copies. You would then be charged $175 for a second original and another $60 for four more copies.
Do not wait until the last minute to request a Certificate to foreign government FDA. I recommend ordering 5-10 copies when you first register a product in the FURLS database, instead of waiting until you need it. The same is true of other types of certificates, such as CE Marking certificates from your Notified Body.
What is a Certificate to foreign government FDA?
If you have a medical device that is registered and listed with the US FDA, then you can obtain a Certificate to Foreign Government from the US FDA.
A Certificate to Foreign Government is a certificate issued by the US FDA verifying that your company may legally export the device, and the device may be distributed in the United States. Regulatory bodies in some countries request a “Certificate of Free Sale.” Still, these are issued by the US FDA for foods, while the agency issues Certificates to Foreign Governments for medical devices.
The name of the certificate is not the same for all countries, and regulators use the terminology most familiar to their country. A Certificate to foreign government FDA (CFG) is, for the export of medical devices that can be legally marketed in the United States (U.S.) that are in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Any medical device that is legally marketed in the U.S. may be exported anywhere in the world without prior FDA notification or approval.
U.S. establishments may request a Certificate to foreign government FDA for any medical device that may be legally marketed in the U.S. A device may be legally marketed in the U.S…
- The establishment must be registered with the FDA;
- The device must be listed with the FDA;
- The device must have a cleared Premarket Notification [(510(k)] , an approved Premarket Approval (PMA) Application (unless exempted by regulation), is a device that was on the market prior to May 28, 1976 (before the Medical Device Amendments to the FD&C Act), or was granted a De Novo classification;
- The device must meet the labeling requirements of Title 21 Code of Federal Regulations (CFR) Part 801 (21 CFR 801) or 21 CFR 809, if applicable;
- The device must be manufactured in accordance with the Quality System (QS) regulation of 21 CFR 820, unless exempted by regulation.
A Certificate to Foreign Government is a certificate issued by the US FDA verifying that your company may legally export the device, and the device may be distributed in the United States.
What is FDA registration?
FDA Registration mandated by the United States Food and Drug Administration responsible for protecting public health from various consumer products such as Drugs, Medical devices, Food & Cosmetics. Product registration plays a vital role in the path of a product that is on its way to the market. If FDA found your unregistered product, it will issue a cease and desist order removing the products from the market.
What is the difference between FDA approval and FDA registration?
REGISTRATION:
- Registration means FDA is aware of the manufacturer and their devices
- The manufacturer cannot claim the device is FDA CLEARED or APPROVED
- They cannot use the FDA logo in labelling their device.
APPROVAL:
- FDA approval means high risk devices are well tested and approved.
- Class III medical devices fall under this category
- It requires a statement or a proof that the high risk devices are safe to use and manufacture.
As a Medical device regulatory consultant we provide regulatory services to manufacturer which helps them to achieve better.
CFG vs. Other FDA Export Certificates: Knowing the Difference
Not all exported medical devices qualify for a CFG. The FDA issues distinct export documents based on the device’s U.S. marketing status:
| Export Certificate Type | Applicable Medical Device Status | Key Regulatory Criteria |
| Certificate to Foreign Government (CFG) | Legally marketed in the U.S. (Cleared/Approved or Exempt). | Active U.S. Establishment Registration & Device Listing. |
| Certificate of Exportability 801(e)(1) | Unapproved in the U.S., but meets foreign buyer specifications. | Complies with foreign laws, labeled for export only. |
| Certificate of Exportability 802 | Unapproved Class II/III devices exported under Section 802. | Requires foreign country approval or Tier 1 authorization. |
| Non-Clinical Research Use Only (NCR) | Products intended purely for research or non-clinical testing. | Must not be used for clinical diagnostic or human therapeutic use. |
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Step-by-Step Guide to Requesting an FDA CFG via CECATS
The FDA processes all export certificate requests electronically through the CDRH Export Certification Application and Tracking System (CECATS).
| Step | Action Item | Primary Task & Details |
| 1 | Access FDA Industry Systems (FIS) | Log in using active FURLS credentials. |
| 2 | Navigate CECATS Application | Select CECATS from the menu and choose New Application ” – ” CFG. |
| 3 | Verify Registration & Listing | Select the appropriate Establishment Registration and confirm device listing numbers. |
| 4 | Attach Supporting Documents | Upload required product labeling, 510(k)/PMA clearance letters, and device details. |
| 5 | Review & Submit | Review the fee estimate, certify application accuracy, and submit the request. |
| 6 | Download e-Certificate | Download the official e-Certificate upon FDA CDRH review and approval. |
Certificate Authentication: Electronic Verification & FECV
The FDA issues official export certificates in electronic PDF format. Foreign authorities, customs officers, and international distributors can verify the authenticity of an issued CFG through the FURLS Export Certificate Validator (FECV).
Verification via QR Code or URL: Each electronic certificate displays a unique Quick Response (QR) code and web address at the bottom. Scanning the code instantly routes to the FECV database, displaying facility details, certificate status, and issue date directly from FDA records.
Apostille & Legalization: If a importing country requires legalization, the electronic certificate can be submitted for an Apostille through the U.S. Department of State. Note that the FDA does not provide physical notarization services.
Manufacturers operating international facilities can also cross-reference compliance pathways across other regions, such as obtaining a manufacturing license via CDSCO India registration or establishing a certified Quality Management System (QMS).
How Operon Strategist Navigates FDA Regulatory Approvals & Export Pathways
Navigating US FDA registration, technical dossiers, quality systems, and foreign export documentation requires specialized regulatory engineering. Operon Strategist provides full-service regulatory consulting to assist medical device companies in securing U.S. market access and executing global expansion:
US FDA Submission & Market Access: Delivering end-to-end support for US FDA (510(k), QMSR, & Registration) submissions, 510(k) predicate matching, and De Novo filings.
Global Product Registration: Leveraging U.S. clearances to accelerate global filings via our turnkey Global Product Registration and Market Intelligence capabilities across Asia, Europe, Middle East, and Latin America.
Quality System & DHF Compliance: Establishing ISO 13485 and FDA QMSR-compliant quality management systems and compiling audit-ready Design History File (DHF) documentation.
Cross-Border Regulatory Filings: Coordinating regulatory submissions across international health authorities, including CDSCO (India), CE Marking (EU MDR / IVDR), SFDA (Saudi Arabia) Registration and UKCA Marking.
Specialized Compliance Services: Providing expert guidance for Drug–Device Combination Product Documentation, Veterinary Medical Devices Registration, BIS Certification, and Regulatory Due Diligence for Medical Devices.
Expanding your device into Europe or the U.S.
CE Marking for EU MDR / IVDR and turnkey US FDA 510(k), QMSR, and Registration
FAQ's
What is a Certificate to Foreign Government FDA (CFG)?
A CFG is an official document issued by FDA CDRH certifying that a medical device can be legally sold in the U.S. and complies with FD&C Act requirements.
How much does an FDA Certificate to Foreign Government cost?
The FDA charges $175 for the initial certificate and $85 for each additional copy requested in the same CECATS submission.
Is a Certificate to Foreign Government the same as a Certificate of Free Sale?
Yes, for medical devices, the CFG serves as the official FDA equivalent of a Certificate of Free Sale. (The FDA issues “Certificates of Free Sale” primarily for foods and dietary supplements).
Can an unapproved medical device get an FDA CFG?
No. Unapproved devices do not qualify for a CFG. They must instead apply for a Certificate of Exportability under Section 801(e)(1) or Section 802 of the FD&C Act.
How long is an FDA Export Certificate valid?
FDA export certificates are typically valid for 24 months from the date of issuance, provided facility registration and device listing remain active.